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This is a Phase â…¢, randomized, double-blind, active-controlled study to assess the immunogenicity and safety of the varicella vaccine,Live (hereinafter referred to as "varicella vaccine")manufactured by Sinovac (Dalian) Vaccine Technology Co., LTD.(hereinafter referred to as "Sinovac").
A total of 642 healthy participants aged 12~15 months will be enrolled. All participants will be randomized at a 1:1 ratio to receive a single dose of varicella vaccine either manufactured by Sinovac (Group A) or Merck Sharp & Dohme (MSD, Group B).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Varicella vaccine group | Experimental | Participants will receive a single dose of investigational varicella vaccine on Day 0. |
|
| Varivax | Active Comparator | Participants will receive a single dose of Varivax on Day 0. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Varicella Vaccine | Biological | lyophilized powder,subcutaneous injection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Seroresponse rate of varicella-zoster virus (VZV) antibody | The seroresponse rate of VZV antibodies on Day 42 after vaccination among susceptible population. | Day 42 after vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric mean concentrations (GMCs) of VZV antibody | The GMC of VZV antibodies on Day 42 after vaccination among susceptible population. | Day 42 after vaccination after vaccination |
| GMC of VZV antibody |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rommel Crisenio M. Lobo, MD | Cardinal Santos Medical Center | Principal Investigator |
| Nancy Nazaire Bermal, MD | San Juan de Dios Educational Foundation, lnc.-Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Juan de Dios Educational Foundation, lnc. | Pasay | 1300 | Philippines | |||
| Cardinal Santos Medical Center |
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| ID | Term |
|---|---|
| D002644 | Chickenpox |
| ID | Term |
|---|---|
| D000073618 | Varicella Zoster Virus Infection |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
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| ID | Term |
|---|---|
| D019433 | Chickenpox Vaccine |
| ID | Term |
|---|---|
| D022283 | Herpesvirus Vaccines |
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
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| Varivax |
| Biological |
lyophilized powder,subcutaneous injection |
|
The GMC of VZV antibodies on Day 42 after vaccination among among all participants.
| Day 42 after vaccination |
| seropositive rate | The seropositive rate of VZV antibodies on Day 42 after vaccination among all participants. | Day 42 after vaccination |
| Geometric mean fold rise (GMFR) from before vaccination of VZV antibody | The GMFR from before vaccination of VZV antibodies on Day 42 after vaccination among all participants. | Day 42 after vaccination |
| Incidence of adverse reactions within 0~42 days after vaccination | Incidence of adverse reactions within 0~42 days after vaccination among all participants | Within 0~42 days after vaccination |
| Incidence of adverse reactions within 0~14 days after vaccination | Incidence of adverse reactions within 0~14 days after vaccination among all participants | Within 0~14 days after vaccination |
| Incidence of serious adverse events (SAE) within 0~42 days after vaccination | Incidence of SAE within 0~42 days after vaccination among all participants. | Within 0~42 days after vaccination |
| San Juan City |
| 1502 |
| Philippines |
| D007239 | Infections |
| D045424 |
| Complex Mixtures |